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Euroheart Score for the Evaluation of In-Hospital Mortality in Patients Undergoing Percutaneous Coronary Intervention

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Euroheart Score for the Evaluation of In-Hospital Mortality in Patients Undergoing Percutaneous Coronary Intervention European Heart Journal (2011) 32, 1398–1408 CLINICAL RESEARCH doi:10.1093/eurheartj/ehr034 Interventional cardiology EuroHeart score for the evaluation of in-hospital mortality in patients undergoing percutaneous coronary intervention Maarten de Mulder 1,2, Anselm Gitt 3, Ron van Domburg 2, Matthias Hochadel 3, Ricardo Seabra-Gomes 4, Patrick W. Serruys 2, Sigmund Silber 5, Franz Weidinger 6, William Wijns 7, Uwe Zeymer 3, Christian Hamm 8, and Eric Boersma 2* 1Medisch Centrum Alkmaar, Alkmaar, The Netherlands; 2Thoraxcentrum, Erasmus MC, Rotterdam, The Netherlands; 3Herzzentrum Ludwigshafen, Ludwigshafen, Germany; 4 5 6 7 Instituto do Coracao, Lisbon, Portugal; Cardiology Practice and Hospital, Munich, Germany; Krankenhaus Rudolfstiftung, Vienna, Austria; Onze Lieve Vrouw hospital, Aalst, Downloaded from Belgium; and 8Kerckhoff Klinik, Bad Nauheim, Germany Received 9 July 2010; revised 30 December 2010; accepted 24 January 2011; online publish-ahead-of-print 22 February 2011 Aims The applicability of currently available risk prediction models for patients undergoing percutaneous coronary inter- http://eurheartj.oxfordjournals.org/ ventions (PCIs) is limited. We aimed to develop a model for the prediction of in-hospital mortality after PCI that is based on contemporary and representative data from a European perspective. ..................................................................................................................................................................................... Methods and Our analyses are based on the Euro Heart Survey of PCIs, which contains information on 46 064 consecutive patients results who underwent PCI for different indications in 176 participating European centres during 2005–08. Patients were randomly divided into a training (n ¼ 23 032) and a validation (n ¼ 23 032) set with similar characteristics. In these sets, 339 (1.5%) and 305 (1.3%) patients died during hospitalization, respectively. On the basis of the training set, a logistic model was constructed that related 16 independent patient or lesion characteristics with mortality, including PCI indication, advanced age, haemodynamic instability, multivessel disease, and proximal LAD disease. In by guest on April 2, 2016 both the training and validation data sets, the model had a good performance in terms of discrimination (C-index 0.91 and 0.90, respectively) and calibration (Hosmer–Lemeshow P-value 0.39 and 0.18, respectively). ..................................................................................................................................................................................... Conclusion In-hospital mortality in PCI patients was well predicted by a risk score that contains 16 factors. The score has strong applicability for European practices. ----------------------------------------------------------------------------------------------------------------------------------------------------------- Keywords Percutaneous coronary intervention † Hospital mortality † Peri-procedural complications † Risk stratification † Predictive model Introduction To identify high-risk patient groups, risk models are developed Since its introduction by the late Andreas Gru¨ntzig in 1979, percu- that relate patient and lesion characteristics to major complications taneous coronary interventions (PCIs) have been applied to the after PCI.2– 8 Especially in situations where it is difficult to select the benefit of millions of patients across the globe. Over the years, most appropriate treatment strategy, they can be of extra value. Risk this procedure has evolved from elective balloon angioplasty in models can then be used to systematically estimate the patient’s risk selected centres to widely available emergency PCI with stent pla- of adverse events. Such estimate might then be used to help the cement. As technology, pharmacology, and operators’ experience physician decide on further patient management, as high-risk with PCI grow, the procedure-associated risks decrease.1 patients might be treated differently than low-risk patients. However, this intervention is still related with mortality, which It is broadly accepted that currently available risk prediction varies between different groups of patients. models for PCI patients have limited applicability, mainly because * Corresponding author: Department of Cardiology, Clinical Epidemiology Unit, Room Bd-381, PO Box 2040, 3000 CA Rotterdam, The Netherlands. Tel: +31 10 7032307, Email: [email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2011. For permissions please email: [email protected] EuroHeart score for the evaluation of in-hospital mortality after PCI 1399 of heavy selection of the patients who form the model- Local investigators were asked to continuously enrol all consecutive development data set. They were either single-centre studies,3,5,8 patients undergoing emergent, urgent, or elective PCI, irrespective of a selected study cohort,2,9 or studies from an era without tech- any other condition. Patients who participated in (randomized) trials niques such as drug-eluting stents; or new anti-platelet medi- or other registries were eligible for inclusion. Investigators who cations.2,4,6,7 These limitations were overcome by Peterson could not warrant enrolment of each and every patient throughout the entire study period were allowed to participate if consecutive et al.,10 who developed a model based on 588 398 procedures patients could be realized from Days 1 to 7 of every calendar from the American NCDR CathPCI Registry database. However, month. We had no system installed to verify whether the principle as this analysis was performed in a geographically different popu- of consecutive patient enrolment was satisfied. 11 lation, its use might be limited for a European population. Data were collected on a broad range of patient characteristics, Additionally, the actual use of risk prediction models in routine including the clinical indication for PCI, cardiovascular risk factors, clinical practice may be an issue. In general, one might expect history of cardiovascular diseases, and co-morbidities. Percutaneous that models that are based on data that are experienced as coronary intervention-related data were collected as well, including ‘close’ will have a good chance of being implemented. In that the number and location of significant lesions, and the ACC-AHA 15,16 respect, models based on European data might more easily pene- lesion classification. An electronic case record form (eCRF) trate European practices than models based on US data. was used for data capture, which was programmed on the basis Furthermore, several risk models did not have separate training of the Cardiology Audit and Registration Data Standards (CARDS) for PCI.17,18 The eCRF was accessible via the Internet for data and validation cohorts.2,7,8,12 Without such separate cohorts, the entry and editing. Data were securely stored on a computer main- training data cannot not be formally validated. As a consequence, Downloaded from frame that was physically located in the European Heart House, their reliability remains uncertain. Nice, France. Automated edit checks were performed to search The Euro Heart Survey of PCIs (EHS-PCI) was developed to for missing data, contradictory data entries, as well as for values obtain quantitative information on the adherence to guidelines that are out of the specified normal range. Additionally, manual and outcomes in European patients undergoing PCI for different edit checks were performed by the data management staff of the indications. The survey was undertaken during 2005–08 and European Heart House. Final editing of the data, as well as data ana- http://eurheartj.oxfordjournals.org/ includes data on 46 064 patients from European hospitals. Thus, lyses, was performed at the Institut fu¨r Herzinfarktforschung Lud- the EHS-PCI provides a unique opportunity to develop (and vali- wigshafen an der Universitaet Heidelberg (IHF), Ludwigshafen, date) a model for the prediction of patient prognosis after PCI, Germany. Any issues that appeared during this process were which reflects the modern clinical practice. In view of the large resolved in cooperation with the local investigators. The protocol of the EHS-PCI Registry was approved by each local number and large variety of hospitals that participated in Ethics Committee when required. All patients provided informed EHS-PCI, the results of this analysis will potentially be applicable consent for processing their data anonymously. to a broad variety of European practices. Primary objective Methods by guest on April 2, 2016 The EHS-PCI Registry was designed to evaluate the application of PCI Registry within the Euro Heart Survey PCI-related treatment guidelines in routine clinical practice. With respect to patient outcome, the current study focuses on mortality. programme In this manner, endpoints that are vulnerable for observer bias, such The EHS programme of the European Society of Cardiology (ESC) as re-myocardial infarction (MI), are avoided and adjudication of such was originally designed as a series of surveys, to obtain information events is not required. All-cause mortality was reported by the local 13 on the application of clinical practice guidelines in the ESC investigators and not adjudicated by a Clinical Event Committee/ member countries, covering the broad spectrum of cardiology prac- Data Safety Monitoring Board. tice,14 an extensive
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